Pre-analytical Factors Affecting ctDNA Analysis in Early and Locally Advanced Breast Cancer

NCT05945290 — Completed, 114 participants, Mayo Clinic

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Pre-Analytical Factors Affecting ctDNA Analysis in Early and Locally Advanced Breast Cancer

Registry	NCT05945290
Status	Completed
Study type	Observational
Enrollment	114 (Actual)
Sponsor	Mayo Clinic (Other); collaborators: National Cancer Institute (NCI)
Conditions	Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Early Stage Breast Carcinoma, Locally Advanced Breast Carcinoma
Interventions	Biospecimen Collection, Electronic Health Record Review (Procedure, other)
Dates	start 2022-07-07, primary completion 2025-06-16, completion 2025-06-16, first posted 2023-07-14, last updated 2025-09-09
Locations	1 site in United States

-Summary

This study evaluates pre-analytical factors affecting circulating tumor deoxyribonucleic acid (ctDNA) analysis in breast cancer that not spread beyond the breast and or lymph nodes (early and locally advanced). ctDNA refers to freely circulating tumor DNA fragments found in the blood plasma. Pre-analytical factors such as blood collection tubes, delays in separation of plasma, centrifugation speeds, storage conditions, shipping and DNA extraction methods can all affect ctDNA measurements. Inappropriate processing can cause breaking down of the membrane (lysis) of peripheral blood cells that release background wild-type DNA and may also cause degradation of circulating tumor-specific DNA fragments. Both mechanisms will dilute levels of ctDNA in plasma and make it more difficult to detect. Evaluating the pre-analytical factors of the collection of blood and left over tissue samples for the research of cancer may help researchers to evaluate the impact of the blood collection/processing and long-term storage from patients with locally advanced breast cancer.

Expand all sections · Collapse all

+Detailed description

PRIMARY OBJECTIVES:

I. To evaluate the impact of blood collection/processing. II. To evaluate the impact of long-term storage of plasma and extracted DNA.

OUTLINE: This is an observational study.

Patients undergo blood sample collection throughout the study. Patients also undergo collection of leftover tissue samples from standard of care (SOC) procedures and have medical records reviewed.

+Arms and interventions

Arm	Type	Interventions	Description
Observational (Biospecimen collection, medical record)		Procedure: Biospecimen Collection; Other: Electronic Health Record Review	Patients undergo blood sample collection throughout the study. Patients also undergo collection of leftover tissue samples from SOC procedures and have medical records reviewed.

Biospecimen Collection (Procedure), also known as Biological Sample Collection, Biospecimen Collected, Specimen Collection: Undergo blood and leftover tissue sample collection
Electronic Health Record Review (Other): Medical records are reviewed

+Outcome measures

Primary outcomes

Change in tumor specific circulating tumor deoxyribonucleic acid (ctDNA) levels [Baseline to 5 years]: Will be measured as tumor fraction (%), using TARgeted DIgital Sequencing (TARDIS).

Secondary outcomes

Change in total cell-free DNA concentration [Baseline to 5 years]: Will be measured in genome copies/ml of plasma, using the Quality Assessment (QA) assay.
Change in total cell-free DNA fragment size profile [Baseline to 5 years]: Will be measured as % fragmented, using the Quality Assessment (QA) assay.
Change in tumor-specific circulating tumor deoxyribonucleic acid (ctDNA) fragment size profile [Baseline to 5 years]: Will be measured as average fragment size, using TARgeted DIgital Sequencing (TARDIS).
Background error rate [Baseline to 5 years]: Will be measured as errors per bp sequenced, measured using TARgeted DIgital Sequencing (TARDIS).

+Eligibility

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* All women > 18 years of age
* Stage I-III breast cancer
* Subject has consented to IRB 2130-00 Tissue Registry

Exclusion Criteria:

* Stage IV breast cancer
* Unwilling or unable to give consent
* Unable to participate for 1 year
* No one with a concurrent cancer except those diagnosed with an in situ cancer or non-melanoma skin cancer

+Locations (1)

Facility	City	Country	Status
Mayo Clinic in Arizona	Scottsdale, Arizona	United States

+Study documents

Informed Consent Form (PDF, 2024-09-24)

+Investigators

Barbara A. Pockaj, MD, Principal investigator, Mayo Clinic

+Funding

NIH grants: UH2CA234306, U01CA243078